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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211821
Company: ALEMBIC

Products on ANDA 211821

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211821

LAMOTRIGINE

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LAMICTAL XR	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022115	GLAXOSMITHKLINE LLC
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200672	ACTAVIS ELIZABETH
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211821	ALEMBIC
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207497	AMNEAL PHARMS
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202383	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201374	PH HEALTH
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202887	RUBICON RESEARCH
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202498	SCIEGEN PHARMS
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213949	YILING
LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207763	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LAMICTAL XR	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022115	GLAXOSMITHKLINE LLC
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200672	ACTAVIS ELIZABETH
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211821	ALEMBIC
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207497	AMNEAL PHARMS
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202383	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201374	PH HEALTH
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213949	YILING
LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207763	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LAMICTAL XR	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022115	GLAXOSMITHKLINE LLC
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200672	ACTAVIS ELIZABETH
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211821	ALEMBIC
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207497	AMNEAL PHARMS
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202383	DR REDDYS LABS LTD
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201374	PH HEALTH
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202498	SCIEGEN PHARMS
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213949	YILING
LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207763	ZYDUS PHARMS

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